23andMe Takes First Step Toward FDA Clearance

July 30, 2012

Company Provides Leadership in Direct-to-Consumer Genetic TestingMountain View, CA – July 30, 2012 23andMe, the leading personal genetics company, today announced that it has delivered its first round of 510(k) documentation to the Food and Drug Administration (FDA). Since its 2006 inception, 23andMe largely created the direct-to-consumer market for genetic analysis. As a leader in personal genetics, the company is now the first in the industry to announce it is working towards FDA clearance. The FDA will review the filing over the next several months and the process of gaining clearance will take time as both the FDA and 23andMe attempt to apply current regulations to a new and growing industry.
“23andMe has pioneered the direct-to-consumer genetic testing industry and we are committed to helping individuals understand their own genetic information through proven DNA analysis technologies and web-based interactive tools,” stated 23andMe CEO and Co-Founder Anne Wojcicki. “23andMe is working proactively with the FDA to ensure the industry delivers high quality information that consumers can trust.”
23andMe’s Personal Genome Service® enables individuals to explore their own DNA and now provides more than 200 health and trait reports as well as genetic ancestry information. The extensive package of health and ancestry reports offered by 23andMe has grown dramatically as the body of research in the general scientific community has continued to make significant advances in assessing the role of genetics in health and diseases. That body of peer-reviewed, published research is regularly curated by the team of 23andMe scientists to determine which information meets the rigorous 23andMe criteria to be incorporated into its health and trait reporting as detailed in https://www.23andme.com/for/scientists/.
“23andMe has always valued the guidance of the FDA and, in fact, engaged the agency in conversations prior to launching the Personal Genome Service® in 2007. Our ongoing conversations with the FDA in the last year, in particular, resulted in a focused approach that resulted in our ability to compile a comprehensive analysis of 23andMe’s direct-to-consumer testing for FDA consideration,” stated 23andMe VP Corporate Development and Chief Legal Officer Ashley Gould.
In providing personalized health reports 23andMe believes that individuals have a fundamental right to their personal genetic data and that genetic data is an essential complement to family history for people to make informed decisions in conjunction with their healthcare provider.
The 23andMe platform is designed to be both fluid and transparent and the filing with the FDA is designed to accommodate this data-driven paradigm. The body of information provided by 23andMe grows over time, not only in adding more traits and health reports, but also in interpreting results based on the continued evolution of scientific literature. 23andMe uses a CLIA-certified laboratory to process customer DNA samples. The 510(k) documentation provided to the FDA builds upon the company’s scientifically sound practices by demonstrating the clinical and analytical validity of its reporting.
“FDA clearance is an important step on the path towards getting genetic information integrated with routine medical care,” explained Ms. Wojcicki. “As the knowledge around personalized medicine continues to grow, consumers should expect their healthcare providers to begin to incorporate genetic information into their treatments and preventative care.”
“We believe our ongoing conversations with the FDA and ultimately securing clearance will be very important as we continue to serve our customers with genetic information that is an essential consideration in their personal health, and continue to grow our community, which is now more than 150,000 strong,” concluded Ms. Wojcicki.
An ongoing service, 23andMe’s Personal Genome Service® provides a wealth of information about an individual’s DNA and updates about new research. Customers can also choose to participate in the company’s unique research programs. By completing online surveys, customers contribute directly to genetic research that can potentially lead to better understanding of and new treatments for a variety of health conditions.
To learn more, visit www.23andMe.com.

About 23andMe

23andMe, Inc. is the leading consumer genetics and research company. Founded in 2006, the mission of the company is to help people access, understand and benefit from the human genome. The company was named by TIME as a “Genius Company” in 2018, and featured as Fast Company's #2 Most Innovative Health Company in 2018. 23andMe has millions of customers worldwide, with more than 80 percent of customers consented to participate in research. 23andMe, Inc. is located in Mountain View, CA. More information is available at www.23andMe.com.

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